Regulatory Compliance


Xodus Quality Management System Certifications

ISO 13485:2012 Quality System Certification   (PDF certificate)
CE Mark MDD 93/42/EEC   (Annev V) (Annev Vs)
US FDA Good Manufacturing Practice (GMP)   (PDF Establishment Registration and CFG Export Certificate)
EC Type Examination Certificate - Electrosurgical Pencils and Electrodes   (PDF Certificate)
Xodus Medical, Inc. is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations

Notified Body / Registrar/ Certification Body

Xodus Medical, Inc. maintains ISO 13485:2012 certification and is audited for compliance by:
LNE-GMED
rue Gaston Boissier
75724 Paris Cedex 15


Xodus Medical, Inc. maintains CE certification and is audited for compliance by:
LNE-GMED
rue Gaston Boissier
75724 Paris Cedex 15


Xodus Medical, Inc. maintains US FDA 21 CFR 820 and is audited for compliance by:
US FDA
Philadelphia District
Pittsburgh Resident Post
7 Parkway Center, Room 250
Pittsburgh, PA 15220

Authorized European Representative

Emergo Group, Inc., Austin, Texas USA
Telephone: +1-512-327-9997
http://www.EmergoGroup.com/services/usa

Countries Xodus Currently Exports To

Australia, Austria, Brazil, Canada, Chile, Denmark, Emirates, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, South Korea, Switzerland, Thailand, Turkey, United Arab & United Kingdom.

Material Safety Data Sheets

Supplied upon request.

Manufacturer Warnings:

Reuse of single use devices is prohibited due to the risk of cross contamination and/or infection.

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